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ISPE Indonesia & Factorytalk Seminar: GxP Quality & Manufacturing Digitization

Date: 1 September, 2022 – 8:30 – 17:00 at Titan Center


Despite the potential of digitalization, the pharma industry has been slower than other sectors in adopting digital tools and in making the required changes in organization, culture and strategic priorities to bring Information Technology into our manufacturing facilities. The Covid-19 pandemic may be a catalyst to finally accelerate the pace of change, and in this seminar, we will take a fresh look at the drivers, applicable regulations, approaches and solutions that are today shaping the Pharma industry and key points to consider when starting your digital journey.  

  • What are the current regulations that we need to consider when implementing modern IT systems? 
  • Learn from peers and companies who have already deployed electronic solutions, what did they learn and what are the challenges and benefits to digitize for Indonesian Pharma 
  • Understand the latest deployment approaches and how to assess and understand the priority of systems for implementation 
  • What are the foundational systems and benefits for manufacturing IT in Pharma, what do you need to know to be successful in your projects! 

Agenda Details

08.30 – 08.45 – Opening/welcome remarks by ISPE Indonesia 

08.45 – 09.45 – Session 1: Global regulatory and best practices update by Factorytalk – David Margetts & Manuh Pitasari 
Session Details:
Regulations and best practices have changed, what do you need to know and what are the relevant take-aways from:
+  New GAMP 5 revision (Aug 2022)
+  Computer Software Assurance
+  Validation 4.0
+  USFDA Quality Management Maturity
+  Data Integrity PICS Jul 2021 

09.45 – 10.00 – Coffee break

10.00 – 11.15 – Session 2: Challenges and opportunities in pharma digitization – A panel discussion by  Factorytalk, Andreas Cahya – Kalbe Group and Meidi Fransisca Siregar – Bayer Indonesia 
Session Details:
+  The drivers for digitization: productivity, quality, new business models 
+  Why is there a slow adoption of technology in Pharma?
+  How does Indonesia compare in the digitization landscape?
+  Why does industry need to review their digital strategy?

11.15 – 12.00 – Session 3: Quality aspects of GxP Digitalization by Factorytalk – Ririn Afrianti
Session Details:
+  How to ensure compliance during adoption/implementation of new technology?
+  What is the role for Quality personnel in new technology projects?
+  What are the key elements to focus on from Quality perspective?

12.00 – 13.30 – Lunch break, demo booth visit
Lunch and visit booths with technology demo: eQMS, EBR, Frontend Operation Platform (zero code)

13.30 – 14.45 – Session 4: Approaches to GxP digitization by Factorytalk – David Margetts
Session Details:
+  How has digitization traditionally been done? 
+  What are the new approaches? 
+  Update on enabling technologies: includes cloud, no/low code, data integration, ML/AI use cases 
+  How to define a digital strategy? assessing and deciding solution technology and priorities, organization and stakeholder alignment 

14.45 – 15.45 – Session 5. What is eQMS in 2022? by Factorytalk – Manuh Pitasari
Session Details:
+  What is eQMS and how is it implemented in 2022?
+  Vendors move to cloud  
+  Overview function/features 
+  Timelines vs results, configurable best practices, validation 
+  Project briefs: including extracts from recent case studies of full remote implementation

15.45 – 16.45 – Session 6. What is EBR in 2022? by Factorytalk – David Margetts
Session Details:
+  What is EBR and how is it implemented in 2022?
+  EBR approach comparison: MES vs automation vs QMS centric vs BR centric vs ERP, what are the functions and pro & cons 
+  On-premise or Cloud? 
+  Timelines vs results, configurable best practices, validation 
+  Project briefs: including extracts from recent case studies of full implementations during Covid

16.45 – 17.00 – Closing and Coffee break



David Margetts
CEO and Co-founder, Factorytalk

Manuh Pitasari
Product and Service Manager, Factorytalk

Ririn Afrianti
Compliance Consultant, Factorytalk

Industry Guest Panelists

Andreas Cahya
Corporate Quality Senior Manager, Kalbe Group

Meidi Fransisca Siregar
Head of Manufacturing IT, Bayer Indonesia 

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